IceCure IceSense3 User manual

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DSR7000002-REV L-IFU FOR CRYOPROBE –EUROPE
IceSense3®, IceCure®, IceSense® and ProSense® are Trademarks of IceCure Medical.
Ltd. In the United States and other countries. IceCure Medical Ltd. and other parties may
also have trademark rights in other terms used herein.
Instruction for Use: Cryoprobe
The information in this document is confidential and is intended
only for use of the recipient. Unauthorized use, duplication,
publication or disclosure is strictly prohibited. If you have received
this document in error, please notify IceCure Medical immediately.
Before using the IceCure Cryoablation system with its accessories
you must read and fully understand the IceCure Cryoablation
system User Manual (for IceSense3® or ProSense®). While this
document is designed to provide instructions in the use of the
cryoprobe with IceCure Cryoablation system, it is not intended to
take the place of the User Manual and of the user training course
which must be completed before using the system.
Intended use of IceCure Cryoablation System
(IceSense3® or ProSense®)
ProSense® cryoablation system is intended for cryogenic
destruction of tissue during surgical procedures by the application
of extreme cold temperatures. The ProSense® cryoablation system
is indicated for use as a cryosurgical tool in the fields of general
surgery (including breast and liver tissue), dermatology, thoracic
surgery (including lung tissue), gynecology, oncology (including
Muskuloskeletal tissue), proctology, and urology (including kidney
tissue). The ProSense® cryoablation system may be used with an
ultrasound device to provide real-time visualization of the
cryosurgical procedure.
This cryotherapy should only be executed if the operative
standard therapy and established therapies cannot be applied.
Indications for Use
ProSense® cryoablation system is intended for cryogenic
destruction of tissue during surgical procedures by the application
of extreme cold temperatures. The ProSense® cryoablation system
is indicated for use as a cryosurgical tool in the fields of general
surgery (including breast and liver tissue), dermatology, thoracic
surgery (including lung tissue), gynecology, oncology (including
Muskuloskeletal tissue), proctology, and urology (including kidney
tissue). The ProSense® cryoablation system may be used with an
ultrasound device to provide real-time visualization of the
cryosurgical procedure.
Urology: The system may be used to ablate prostatic tissue. The
system may be used to ablate kidney tissue including renal cell
carcinoma. The system may be used for the ablation of prostate
tissue in cases of prostate cancer and benign prostatic hyperplasia.
Oncology: The system may be used for ablation of cancerous or
malignant tissue. The system may be used for ablation of benign
and malignant breast tumors. The system may be used for ablation
of benign and malignant lung tumors. The system may be used for
ablation of benign and malignant musculoskeletal tumors. The
system may be used for ablation of benign and malignant liver
tumors. The system may be used for ablation of benign tumors. The
system may be used for palliative intervention.
Dermatology: The system may be used for the ablation or freezing
of skin cancers and other cutaneous disorders.
Gynecology: The system may be used for the ablation of malignant
neoplasia or benign dysplasia of the female genitalia.
General Surgery: The system may be used for the ablation of
leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell
tumors of the eyelid or canthus area, ulcerated basal cell tumors,
dermatofibromas, small hemangiomas, mucocele cysts, multiple
warts, plantar warts, hemorrhoids, anal fissures, perianal
condylomata, pilonidal cysts actinic and seborrheic keratoses,
cavernous hemangiomas, recurrent cancerous lesions. The system
may be used for the destruction of warts or lesions. The system may
be used for the palliation of tumors of the oral cavity, rectum, and
skin. The system may be used for ablation of breast fibroadenomas
and breast tumors.
Thoracic Surgery: The system may be used for the ablation of
arrhythmic cardiac tissue. The system may be used for the
ablation of cancerous lesions, including lung tissue.
Proctology: The system may be used for the ablation of benign or
malignant growths of the anus and rectum. The system may be
used for the ablation of hemorrhoids.
This cryotherapy should only be executed if the operative standard
therapy and established therapies cannot be applied.
Clinical decisions
The practitioner is solely
responsible for all clinical use of
the IceCure cryoablation system
and for any results obtained with
the device.
Figure 1: Single use cryoprobe label
A number of internationally
recognized symbols relating to
safety requirements and
standards are found on the
cryoprobe label. These symbols
are listed in the IceCure
cryoablation system User Manual.
Cryoprobes are not compatible with magnetic
resonance imaging
Cryoprobe Selection
Cryoprobes are fragile and can be damaged if mishandled.
Do not use a cryoprobe that has been bent, dropped, hit
against a hard surface or compromised in any manner, as
damage to the cryoprobe may have occurred.
The cryoprobe tip must be covered when not within the target
tissue.
Prior to starting a procedure, select a cryoprobe according to your
clinical judgment.
Figure 3: Cryoprobe selection

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DSR7000002-REV L-IFU FOR CRYOPROBE –EUROPE
IceSense3®, IceCure®, IceSense® and ProSense® are Trademarks of IceCure Medical.
Ltd. In the United States and other countries. IceCure Medical Ltd. and other parties may
also have trademark rights in other terms used herein.
Cryoprobes up to 250 mm shaft length are intended for penetration
and freezing of soft tissue and can be used in percutaneous
procedures as well as laparoscopic, while longer cryoprobes are
typically used for laparoscopic procedures under reduced
mechanical stress.
Figure 7: For illustration only Color Tag
labels for cryoprobe and the matching
introducer
The cryoprobe serial number (S/N) appears on the
screen/cryoprobe package/cryoprobe plastic grip.
Cryoprobe connection
Never reuse a single-use cryoprobe.
Connect the cryoprobe to the cryohandle, while maintaining
sterility of the cryoprobe:
1- Remove the plug that covers the cryoprobe connection point.
2- Insert the cryoprobe into the insertion point in the handle as
shown on the system screen and screw it until a “NEXT” button
appears on screen then confirm screwing by an additional slight
rotation to confirm that cryoprobe connection is secured.
3- Remove the cryoprobe tip protector.
When done, press “NEXT” on the
screen.
: Cryoprobe connection screen5ureFig
Cryoprobe operation
Perform a functional pre-test to ensure system efficacy and safety
as explained in the User Manual.
If a functional problem occurs or there is any unusual appearance
(such as frost on the plastic cover near the cryohandle, bubbles or
any unusual appearance), press "CANCEL" on the system screen
and follow system instructions until you are required to safely
remove the cryoprobe from the cryohandle. Before operating the
cryoablation system, make sure you have completed all pre-
operational stages.
You must NOT allow the freeze process to start before
the cryoprobe tip is actually within the target tissue.
Before activating the freeze cycle, insert the cryoprobe into the
target tissue under imaging guidance following the steps:
1. Confirm longest dimension of the target tissue
2. Plan the trajectory of the cryoprobe prior to placement.
When clinically safe, the center of the cool zone shall be along
the longest dimension of the target tissue.
3. The black safety mark should be completely in the tissue.
4. In percutaneous approach, perform a 3 mm skin incision (for
example using #11 blade) before the cryoprobe is inserted.
5. Position the tip of the cryoprobe at the distal end of the long
axis of the target tissue, when clinically safe
6. Center of the cool zone, should be in the center of the tissue
to be ablated (see figure 2 for the distance of the cool zone
from the tip of the cryoprobe that is visible under Ultrasound
imaging)
7. Maintain sterility and patient safety.
Be aware of the markings on the cryoprobe: the wide black mark
closest to the tip is the safety mark. In percutaneous procedures it
must be completely inside the tissue to avoid skin burns. The rest
of the marks indicate depth of cryoprobe insertion: each mark
equals one centimeter with distinctive markings at 5 and 10 cm (50
& 100 mm).
Figure 6: illustration of FAP7200000 cryoprobe markings on the cryoprobe
Once you have verified the cryoprobe is located in its right place,
you may begin freezing.
Portions of the cryoprobe other than the freeze zone,
including the plastic cover that is located near the
cryoprobe handle, may become cold and cause tissue
damage. If unwanted freezing occurs, immediately stop the
freezing process. In case of frost on shaft, start Extraction if
possible. If not, wait for passive Thaw. In both cases, use skin
protection techniques.
To prevent injury, cryoprobes must be closely observed during use
for signs of unwanted freezing.
During Thaw, the ice ball melts partially or totally depending on the
thaw time and the tissue properties.
Keep the cryoprobe location steady in the target tissue during all
of the thaw period. Control the process under Ultrasound or any
other imaging system.
The Extraction step occurs at the end of every treatment. Its
purpose is to allow the cryoprobe’s removal from the target tissue
in the fastest and safest way.
At the end of the extraction step, a message will be displayed on
system screen. Wait for the message, then gently remove the
cryoprobe from the target tissue.
Do not force removal of the cryoprobe from the tissue as it might
increase the risk of hematoma.
If the cryoprobe cannot easily be extracted from the tissue, press
the “Extraction” icon on screen to initiate another Extraction cycle.
In case the Extraction process isn’t available, wait for passive Thaw.
Before removing the cryoprobe from the tissue, make
sure the freeze effect has been deactivated and the
cryoprobe can be easily withdrawn. Never use excessive force to
extract the cryoprobe.
Cryoprobe disassembling
After removing the cryoprobe from the target tissue, and only if
system screen displays a message that it is safe to disengage the
cryoprobe, detach the cryoprobe from the cryohandle as follows:
1. Unscrew the used cryoprobe from the cryohandle and
dispose of it appropriately.
2. Remove the single-use sterile cover from the cryohandle.
3. Close the cryohandle with the covering plug.
Figure 4: The cryoprobe

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DSR7000002-REV L-IFU FOR CRYOPROBE –EUROPE
IceSense3®, IceCure®, IceSense® and ProSense® are Trademarks of IceCure Medical.
Ltd. In the United States and other countries. IceCure Medical Ltd. and other parties may
also have trademark rights in other terms used herein.
Following each cryosurgical procedure, discard the single use
devices (single-use cryoprobe, single-use temperature sensor,
cryohandle, flexible hose and touch screen covers and sleeves).
All single use devices are considered to be medical waste and must
be disposed of in accordance with medical waste laws and hospital
standards. Sharp objects such as the cryoprobe and temperature
sensor must be disposed of in a sharp container.
The cryoprobes are single use and are suppliedin single
use packaging. Never reuse a single-use cryoprobe.
Reprocessing single use device (like the cryoprobe, temperature
sensor) could affect the mechanical or performance or
microbiological properties of the product.
Contraindications
Severe infection, uncorrectable coagulopathy, hemodynamic or
respiratory instability.
Predictable Adverse Events
General surgery/ Minimal Invasive Procedures - Mild/moderate
adverse events: infection, bleeding, pain, fever, thermal injury,
injury to adjacent organs, pneumonia, fall, internal adhesions,
incomplete treatment changes in the laboratory parameters-
elevation in aspartate aminotransferase and/ or alanine
aminotransferase level (this reflects hepatocellular damage),
minimal self-limited serum bilirubin level elevation, hemorrhage,
hematoma, myoglobinemia, pleural effusion, hemothorax,
pneumothorax, thrombosis, diarrhea, nausea, deep vein
thrombosis (DVT), transient ischemic attack, hypertension,
hypothermia, treatment site reaction, local neuropathy, frostbite,
skin burn, vagal reaction, vomiting, needle seeding, user accidental
injury. Severe adverse events: infection, thermal injury, procedure
done on the wrong patient/ part of the body, retention of foreign
object after surgery, pulmonary emboli, congestive heart failure,
stroke, fall, severe changes in the laboratory parameters-elevation
in aspartate aminotransferase and/ or alanine aminotransferase
(this reflects hepatocellular damage), life threatening serum
bilirubin level elevation, perirenal fluid collection, hemorrhage,
cryoshock (hypotension), respiratory compromise, multi organ
failure, disseminated intravascular coagulation (DIC), abscess,
pleural effusion, hemothorax, pneumothorax, thrombosis of the
portal vein branches, allergic/anaphylactoid reaction,
angina/coronary ischemia, myocardial infarction, arrhythmia,
atelectasis, adjacent organ injury.
Cryoablation procedure in general - Mild/moderate adverse
events: hematoma, hemorrhage, infection, pain, fever, thermal
injury, thrombocytopenia, coagulation dysfunction. Severe
adverse events: haemorrhage, infection, tumor seeding, thermal
injury, thrombocytopenia, coagulation dysfunction, parenchymal
or cryoablated organ injury, incorrect interpretation of post-cryo
changes, intra vessels / intra bone gas, emboli, myocardial
infarction.
Percutaneous ablation procedure - Mild/moderate adverse
events: percutaneous hematoma and bleeding infection, adjacent
organ injury, CT related adverse effects: radiation, elevated
creatinine and renal function injury, reaction. Severe adverse
events: percutaneous bleeding, infection, adjacent organ injury, CT
related adverse effects: radiation, acute renal injury, anaphylactic
shock in reaction to contrast agent admission, gas emboli.
Laparoscopic procedure - Mild/moderate adverse events: vascular
and visceral injury, general anesthesia related AE,
pneumoperitoneum (that can cause hemodynamic alterations),
post procedural abdominal adhesions, abdominal wall hematoma,
wound infection and fascial injury. Severe adverse events: vascular
and visceral injury, general anesthesia related AE, port site
metastasis, pneumoperitoneum (that can cause hemodynamic
alterations), post procedural abdominal adhesions, cryoprobe and
trocar insertion include injuries to major retroperitoneal vessels
and to bowel, abdominal wall hematoma, fascial dehiscence and
herniation, umbilical hernia, and umbilical wound infection.
Breast - Fibroadenoma and breast cancer: Mild/ moderate
adverse events: bleeding from breast puncture site, local breast
hematoma, local breast infection and thermal injury to the breast
skin, breast skin bruising, breast swelling, ecchymosis, edema, fat
necrosis. Severe adverse events: thermal injury.
Urology - Renal and Prostate: Mild/moderate adverse events:
adjacent organ injury, allergic reaction, bleeding, DVT, cystitis ,
Hematuria, hypotension, Idiosyncratic reaction, ileus, infection,
pleural effusion, pneumothorax, probe site paresthesia, mild renal
failure, renal infract, voiding dysfunction, urinary tract obstruction,
hematomas, ejaculatory dysfunction, erectile dysfunction, penile
paresthesia, pelvic pain, perineal pain. Severe adverse events:
abscess, adjacent organ injury, renal artery/renal vein injury,
anaphylactic reaction, coronary ischemia, myocardial infraction,
bleeding, death, DVT, hypotension, pulmonary embolism, severe
renal failure, stroke, Idiosyncratic reaction, ileus, infection lumbar
radiculopathy, pelvic vein thrombosis, pleural effusion,
pneumothorax, renal hemorrhage , severe urinary tract
obstruction, renal vein thrombosis, rectourethral fistula, scrotal
edema, ureteral stricture, renal infract, sepsis, urinary tract leak,
urethral sloughing, urethral stricture, urinary fistula, urinary
frequency/urgency, urinary incontinence, urinary retention,
bladder neck contracture, stroke, need for transfusion due to
hemorrhage, tumor seeding, gastro intestinal tract injury.
Thoracic surgery - Lung and cardiac arrhythmia: Mild/moderate
adverse events: frostbite, respiratory failure, pneumothorax,
Hemothorax, pleural effusion, pneumonia, empyema, hemoptysis,
lung collapse, thrombosis, phrenic nerve palsy, Pain, fever, cough,
back pain, skin injury, pulmonary emboli, Loss of speech
(temporary aphasia from laryngeal nerve damage), arm paresis,
burn, hemorrhage, pneumonitis. Severe adverse events:
respiratory failure/arrest, pneumothorax, hemothorax, pleural
effusion, pneumonia, empyema, lung collapse, thrombosis, phrenic
nerve palsy, subcutaneous emphysema, death due to Acute
respiratory distress syndrome, pulmonary emboli, prolonged chest
tube drainage, prolonged intubation pulmonary
insufficiency/failure, hemorrhage, dyspnea, atelectasis.
Liver - Mild/moderate adverse events: changes in the laboratory
parameters-elevation in AST (Aspartate Aminotransferase) and/ or
ALN (Alanine aminotransferase) level - reflects hepatocellular
damage of normal liver parenchyma, minimal self- limited serum
bilirubin level elevation, hematoma, hemorrhage, nyoglobinemia,
pleural effusion, hemothorax, pneumothorax, thrombosis. Severe
adverse events: Severe changes in the laboratory parameters-
elevation in AST (aspartate aminotransferase) and/ or ALN (Alanine
aminotransferase) level - reflects hepatocellular damage of normal
liver parenchyma, life threatening serum bilirubin level elevation,
hemorrhage, cryoshock (hypotension, respiratory compromise,
multi organ failure, DIC), post procedural abscess- due to conduit
ascending bacterial (especially in patients with history of biliary
interventions and biliary enteric anastomosis ), pleural effusion,
hemothorax, pneumothorax, hrombosis of the portal vein
branches.
Musculoskeletal - Mild/moderate adverse events: muscular injury,
pain, swelling, osteonecrosis, osteomyelitis, chondrolysis, nerve
palsy, motor dysfunction, peri-ablational neuropathies. Severe
adverse events: compartment syndrome osteonecrosis,
osteomyelitis, chondrolysis, nerve palsy, motor dysfunction, peri-
ablational neuropathies, bowel damage, urinary tract damage,

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DSR7000002-REV L-IFU FOR CRYOPROBE –EUROPE
IceSense3®, IceCure®, IceSense® and ProSense® are Trademarks of IceCure Medical.
Ltd. In the United States and other countries. IceCure Medical Ltd. and other parties may
also have trademark rights in other terms used herein.
pericardial effusion in (in chest wall ablations), avascular necrosis
of femur head, ureteral stricture.
Gynecology - Mild/ moderate adverse events: spotting, urinary
tract infection, treatment site infection, uterine bleeding,
genitourinary perforation, pelvic pain.
Dermatology - Mild/ moderate adverse events: skin
burn/frostbite, wound complication and wound infection.
Cryoprobe technical specifications
The packed cryoprobes shall be stored in a dry, cool, well-ventilated
and clean environment without corrosive gas.
In general, IceCure's Cryoprobes are available in various diameters
(2.4mm to 3.4mm), various ice ball shapes (Spheric, Ellipsoid),
various tips (trocar, blunt and pencil) and various lengths (124mm
to 403mm external shaft length) according to the expected
application, treated tumor size and surgery approach.
The opening of the cryoprobe pouch should be
where the “PEEL HERE” label is positioned.
Figure 6: “Peel Here” label
Ref number: FAP 7100000, FAP 7200000, FAP 7400000, FAP
7410000, FAP 7910000, FAP 7600000, FAP 78000000 and
FAP 7820000.
* Certain configurations are not available in some regions.
Temperature Range: -196C to +40C
Needle diameter: 2.4mm (13G) or 3.4mm (10G)
IceCure Medical, Inc.
41-18 Christine Ct
Fair Lawn, NJ, 07410, USA
[e-mail]
Tel: [phone]
IceCure Medical Ltd.
7 Haeshel St., 2nd floor,
Caesarea 3079504, Israel
[e-mail]
Tel: [phone]; Fax: [phone]
MedNet EC-REP GmbH –Authorized Representative of
IceCure Medical Ltd.
Borkstraße 10, 48163 Münster, Germany
Tel [phone]
Fax [phone]